Many types of surgical drapes are known. Some include an adhesive layer for adhering the surgical drape to a patient's skin or other surface. One such drape is an incise drape. An “incise drape” is one where a surgical incision is made directly through the drape and into a patient. By definition, a skin surface covered by a sterile incise drape is bacteria-free (i.e., sterilized) at the beginning of a surgical procedure. Ideally, the skin surface remains bacteria-free during the procedure, resisting the transfer of bacteria from, for example, gloves, instruments, and sponges that may come in contact with, not only the surgical wound, but also the surrounding skin. A drape's barrier and antimicrobial properties are typically effective only so long as the drape is securely attached to the skin.
As described in U.S. Pat. No. 6,742,522, many of today's surgical procedures involve the use of a surgical incise drape. The incise material is usually a clear polymeric film with an adhesive on one side that is covered with a release liner. Two known suppliers of incise materials are Minnesota Mining and Manufacturing Co. and T. J. Smith and Nephew Ltd. Typically, incise material is used in connection with towels or surgical drapes to maintain the surgical area as clean and sterile as possible in order to help reduce the risk of infection. Once the surgical area of the patient has been cleaned and treated with an antimicrobial, the surgical site is squared-off by the use of sterile towels and a surgical drape that has a fenestration (i.e., a specifically designed shape and opening formed therein) of a size that is larger than the expected size of the incision. An incise material is then used to cover all or a portion of the patient's skin left exposed by the towels or the fenestration in the surgical drape or main sheet.
One purpose for using the incise material is to help reduce the migration of germs and bacteria into the incision site. This reduction is needed because, despite cleansing of the skin, the pores still contain additional germs and bacteria. Such germs and bacteria can migrate to the surface as the skin is moved and worked during the course of the surgical procedure. By covering the skin with incise material, however, a lower incidence of surgical site contamination occurs.
Incise drapes typically come in sizes as small as 13×18 centimeters (5×7 inches), but are usually 40×30 centimeters (16×12 inches) through 90×120 centimeters (36×48 inches) and larger. Conventional surgical drapes usually consist of an antimicrobial film incise material covered by a one-piece silicone-coated paper release liner having equal dimensions to the film so that the adhesive is protected. Typical practice is for two people to stand on opposite sides of the operating table with sterile gloved hands, each within the sterile field. One person grips the handle portion of the drape (e.g., a 10- to 15-centimeter film margin that is free of adhesive), while the other person takes the release liner and pulls it away from the underside, exposing the adhesive. The drape is then applied to the patient at the surgical site and subsequently smoothed out and pressed onto the patient with a sterile towel. With larger drapes, this might require three or more people.
Current incise drapes are usually large and cumbersome to apply to the patient without wrinkles and without the drape sticking to itself in the process. As described above, drape application usually requires at least two or three people, creating a drain on operating room personnel and contributing to rising hospital costs. Applying conventional incise drapes can be a frustrating experience, even for those skilled in the art of applying these drapes. Surgical incise drapes are typically flimsy (so as to be very conformable to the contours of the skin) and include an aggressive pressure-sensitive adhesive for adhesion to the skin. These two characteristics, when combined with the large size of many incise drapes, frequently results in the application of a wrinkled drape.
For proper functioning of a surgical incise drape, it is important that the incise drape be wrinkle-free after it is applied, especially directly at the incision point in order for the surgeon to be able to make a clean surgical incision. Wrinkles in the drape make it difficult for the surgeon to see through to the skin (i.e., translucency and visibility are important). Furthermore, if the incise drape includes wrinkles, the incise drape may not prevent bacteria on the skin from getting into the wound. Maintaining a sterile surface at the point of incision helps prevent surgical wound infections.
In an attempt to address this important consideration, U.S. Pat. No. 6,742,522 discloses the use of a film handle at a leading edge of a flexible film used as the backing of a surgical incise drape. The film handle is preferably formed of a relatively stiff material as compared to the flexible film. Although the configurations described therein purportedly lead to wrinkle-free application of the surgical incise drapes, the methodology for such application is complicated.
The importance of an incise drape being wrinkle-free after it is applied, especially directly at the incision point in order for the surgeon to be able to make a clean surgical incision, is also discussed in U.S. Pat. No. 5,985,395. Indeed, there is a need for improved surgical incise drapes and methods of applying such drapes to a patient.
While a carrier has been used to apply certain medical laminates to a patient's skin, those applications are limited. For example, U.S. Pat. No. 6,350,339 discloses a non-stretchable wound dressing having a flexible, non-stretching cover sheet having adhesive on one side thereof and having two spaced strip-form gripping tabs at opposite ends thereof. The cover sheet covers a urethane wound dressing with the adhesive of the cover sheet being in contact with the urethane and the urethane having an adhesive layer on an opposite side thereof. For storage and prior to application to a patient, the adhesive of the urethane wound dressing is in contact with a releasable surface of a carrier, such as cardboard. For application to a patient, one of the cover sheet gripping tabs is pulled so as to release the cover sheet and wound dressing from the carrier, the cover sheet preventing stretching of the wound dressing. The combination is then applied to a patient, again the cover sheet preventing stretching of the wound dressing. The other gripping tab of the cover sheet is then pulled to separate the cover sheet from the wound dressing, leaving the wound dressing on the patient with no stretching thereof.
Further, a flexible but non-stretching backing for a urethane wound dressing is disclosed in European Patent Publication No. EP 0 066 899 A2, which is directed toward a delivery system for adhesively affixed copolymer medical coverings such as adhesive bandages, surgical drapes, medical dressings and the like. The delivery system includes a film sheet disposed on and supported by a film sheet carrier. The carrier remains in contact with the wound dressing using an adhesive while the dressing is being applied to the patient and is separated from the wound dressing only after the dressing has been placed on the patient, thereby eliminating stretching during application of the dressing. A carrier removal tab is affixed to the back of the film sheet carrier to facilitate its separation from the film sheet after affixation of the film sheet to the subject. The carrier is described as being relatively un-stretchable and rigid as compared to the film sheet. The carrier is also described as being bendable to conform generally to the contours of the part of the biological subject for supporting the film sheet until after the film sheet is affixed to cover the selected part of the biological subject. The only material described for the carrier therein is a polyester film sold by E.I. du Pont de Nemours of Wilmington, Del. under the trade designation, MYLAR. As described in the background discussion of U.S. Pat. No. 6,350,339, however, MYLAR does not possess the flexibility desired in a material suitable for the application of a flexible wound cover contouring agent.
Despite various attempts to provide surgical incise drapes that are easy to apply effectively, improvements are needed in that regard. Importantly, conformability to a patient's individual body features, without sacrificing ease of application, is in need of improvement for maximizing effectiveness of surgical incise drapes in warding off harmful bacteria.